Proximal actuator for medical device

ABSTRACT

The proximal actuator is operable with various medical devices which have one tube or wire axially movable with respect to another tube or wire (e.g., a guide wire operable within an actuation sleeve). The actuator includes a deployment handle which is transversely or laterally (not axially) removably attachable. The actuator includes first retaining device (e.g., spring clip grip) removably attachable to the actuation sleeve and second retaining device removably attachable to the wire member. The second retainer moves relative to the first retainer such that the sleeve slides over the wire thereby moving a medical device at the distal end of the system. The handle may have a grip and a sleeve defining an aperture and a sliding member in the sleeve. The slide member is rotatably mounted to one retainer and is threadably mounted to the other retainer such that upon rotation, one moves with respect to the other.

[0001] This is a regular patent application based upon provisionalpatent application No. 60/440,932, filed Jan. 17, 2003. This applicationis related to U.S. patent application Ser. No. 10/346,729, filed Jan.17, 2003, which is a continuation-in-part of U.S. patent applicationSer. No. 09/875,342 filed Jun. 6, 2001, which is a continuation-in-partof U.S. patent application Ser. No. 09/660,380 filed Sep. 12, 2000, nowpending, which is a continuation of U.S. patent application Ser. No.09/376,120 filed Aug. 17, 1999, which is a regular patent applicationclaiming benefit of provisional U.S. patent application Serial No.60/127,438 filed Apr. 1, 1999. The present application is also relatedto U.S. patent application Ser. No. 09/540,959 filed Mar. 31, 2000, anda continuation-in-part of U.S. patent application Ser. No. 09/376,120filed Aug. 17, 1999.

[0002] The present invention relates to a proximal actuator for amedical device wherein the medical device, at its proximal end, has onetube or wire which axially moves with respect to another tube or wire.The proximal actuator, when transversely or laterally (notlongitudinally) removably mounted, permits the operator to move one wireor tube with respect to the other wire or tube. In on embodiment, theactuator is attached to deployment system for an expandable frame and anassociated filter system which mounts onto the expandable frame which isused during catheterization of a patient.

BACKGROUND OF THE INVENTION

[0003] During catheterization of a patient, a guide wire is directedthrough the patient's blood vessel to the site of interest. For example,the physician may wish to utilize a balloon catheter in order to enlargea partially obstructed blood vessel at a certain location in thepatient's vascular system. To do this, the physician utilizes a guidewire which is directed through the patient's vascular system to theparticular site for balloon catheterization. Various medical devices arepercutaneously inserted into the patient's blood vessel utilizing theguide wire. The balloon catheter, for example, is mounted at the distalend of an elongated tube. The guide wire is placed in the lumen of theballoon catheter tube such that the balloon catheter can be threadedover the guide wire, through the vascular system and placed at the siteof interest by following the guide wire.

[0004] In order to enlarge a partially obstructed blood vessel, aphysician may use various surgical techniques and biomedical devices ortools including balloon catheters, scrapers or other known medicaldevices. However, the utilization of these devices sometimes results ina release of an embolus (embolic material) which is an abnormal particlecirculating in the blood. In order to reduce complications arising fromthese medical procedures, physicians sometime utilize filters disposeddownstream of the site of interest. As used herein the term “downstream”refers to an item that is spaced a distance apart from a referenced itemand in the direction of blood flow through the blood vessel.

[0005] U.S. Pat. No. 4,619,246 to Molgaard-Nielsen et al. discloses acollapsible filter basket. The basket includes a woven mesh but does notoperate on a guide wire.

[0006] U.S. Pat. No. 4,723,549 to Wholey et al. discloses a filter whichis expanded based upon inflation of a balloon acting as a donut mountedto expanding frame members of the filter disposed about the guide wire.

[0007] U.S. Pat. No. 5,053,008 to Bajaj discloses a filter which isexpanded based upon inflation of a tubular balloon.

[0008] U.S. Pat. No. 5,108,419 to Reger et al. discloses a filter forcapturing particles of plaque which includes a laterally (radially)collapsible bag with a plurality of longitudinally displaced filtercones therein. The bag has a draw string about its mouth which opens andcloses the bag both laterally (to deploy or pull-up the conical filters)and longitudinally (to wrap the conical filters and the bag into asmall-diameter shape). Each conical filter includes flexible tensionsupports which carry filter screens or mesh and which open and closebased upon the respective longitudinal position of a generally statichub at the end of a guide wire running through the filter basket system.In another embodiment, a single conical filter is utilized with a filterstocking or collapsible bag thereabout. All the tension supports areflexible enough to wrap and twirl within the collapsible bag and wrapthe conical filter(s) about the guide wire. Also, a draw string closesthe collapsible bag in all embodiments. The flexible tension supports orradial ribs are resilient enough to provide force to spread the conicalfilter mesh across the lumen of the blood vessel.

[0009] U.S. Pat. No. 5,549,626 to Miller et al. discloses a filterdeployed from the inside of a hollow tube by axial movement of an innercatheter.

[0010] U.S. Pat. No. 5,695,519 to Summers et al. discloses a wire, whichcontrollably moves forward and aft, to open and close a generallyconical filter by acting on the filter's mouth.

[0011] U.S. Pat. No. 5,810,874 to Lefebvre discloses a filter includingstrips that are radially opened by moving an inboard ring towards anoutboard ring. The rings retain forward and aft ends of the strips. Thefilter can be detached from the guide wire.

[0012] U.S. Pat. No. 5,814,064 to Daniel et al. discloses one filtersystem which utilizes various types of inflatable ribs, tubes or strutsand a second filter system wherein the filter material is deployed bylongitudinal movement of a push-pull wire relative to a generally staticdistal end of a tube (see Daniel FIGS. 15-16B). In one embodiment,struts carry filter mesh and are forced radially outward by axialmovement of a wire attached to the apex of the conical filter relativeto a static tube end. In a collapsed position, the filter is disposedoutboard of the static tube. In another embodiment, wire filter mesh hasa conical memory shape such that when deployed outboard of a closed endcylinder, a conical filter is created by the memory shaped metallicfilter. In another embodiment, only the open end of the conical filterhas a memory shape. A further embodiment utilizes memory shaped filtermesh, a cinch wire and a push guide wire.

[0013] U.S. Pat. No. 5,911,734 to Tsugita et al. discloses a conicalmesh filter with a proximal end strut structure connected to the distalend of a guide wire. Accordingly, the distal end of a guide wire is notdownstream of the filter (see Tsugita FIGS. 2-8B). In anotherembodiment, the filter (conical or concave) is attached to radiallyoutwardly biased struts. In a closed state, the biased struts areretained within a sheath. Upon axial movement of the guide wire relativeto the sheath, the struts are moved beyond the sheath, they spring opento expand and deploy the filter. (See Tsugita FIGS. 10-11B). In afurther embodiment, an egg beater filter is deployed. One embodiment ofthe egg beater filter utilizes a compressive spring which pulls fore andaft ends of expandable struts together, thereby radially expanding afilter basket with one side carrying filter mesh thereon. In otherwords, the filter is spring actuated. (Tsugita FIG. 15A). In another eggbeater embodiment, pressure wires “spring” radially outward deployingconical cage wires which retain a mesh filter. (Tsugita FIG. 16). Ascroll filter is also disclosed. A further embodiment discloses a filterwith an expansion frame apparently made of memory shaped material.Tsugita FIG. 19 discloses a filter with a distally extending innersheath having filter strut ends attached thereto and an outer sheathhaving the other filter strut ends attached thereto. To open the filter,the outer sheath is moved distally towards the inner sheath therebycausing the filter struts to buckle radially outward. The struts may bepacked densely to form a filter or filter mesh material may be drapedover the struts. In a different embodiment, an outer sleeve islongitudinally slitted. (Tsugita FIG. 23, 23A). When the distal end ofthe slit outer sleeve is pulled proximally, the slitted region bucklesradially outward to provide an egg beater filter. The expanded cage canbe draped with filter mesh.

[0014] PCT Published Patent Application WO 96/01591 discloses a concavefilter deployed by axially shortening the distance between the filtermouth and the filter apex (attached to a distal end of a guide wire).The filter mouth is sprung open by tethers fixed at one end to a statictube. A rod extends through the filter to its apex. The filter opensbased upon the relative position of the filter apex on the rod (whichextends beyond the apex to form the distal end of the guide wire) andthe static tube.

OBJECTS OF THE INVENTION

[0015] It is an object of the present invention to provide an actuatorwhich is transversely or laterally detachably mountable on a proximalregion of a one tube or wire which axially moves with respect to anothertube or wire. In one embodiment, the actuator permits controllabledeployment of a radially expandable frame utilized duringcatheterization.

[0016] It is an additional object of the present invention to provide adetachable actuator for a medical device that permits movement of onetube or wire which axially moves with respect to another tube or wire.

[0017] It is a an additional object of the present invention to providea controllable proximal actuator that includes a thumb screw control.

SUMMARY OF THE INVENTION

[0018] The proximal actuator is operable with many types of medicaldevices provided that these medical devices have one tube or wire whichaxially moves with respect to another tube or wire (sometimes herein a“tube-in-tube” device). The proximal actuator includes a deploymenthandle transversely or laterally removably attachable to thetube-in-tube device. One tube-in-tube device expands or contracts afilter at the distal end of the tube-in-tube system and is used incatheterization procedures. One example of a tube-in-tube device is aguide wire member and an actuation sleeve slidably disposed about theguide wire member. The actuation sleeve sometimes carries an expandableframe for capturing embolic material. The deployment handle (proximalactuator) includes a first retaining device (e.g., a spring clip grip)which is removably attachable to the actuation sleeve and a secondretaining device removably attachable to the wire member. The secondretaining device is moveable relative to the first retaining device suchthat as the actuation sleeve slides over the wire member the expandableframe is opened and closed. Preferably, the handle contains a gripportion and a sleeve defining an aperture and a sliding member in thesleeve. The slide member is rotatably mounted to one of the retainingdevices and is threadably mounted to the other retaining device suchthat upon rotation, one retaining device moves with respect to the otherand the actuation sleeve concurrently moves with respect to the guidewire.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Further objects and advantages of the present invention are foundin the detailed description of the preferred embodiments when taken inconjunction with the accompanying drawings in which:

[0020]FIG. 1 diagrammatically illustrates a cross-sectional view of thedeployed filter device for capturing embolic material in a blood vessel(one type of medical device distally operable with the proximalactuator);

[0021]FIG. 2 diagrammatically illustrates a collar at either the foreend or the aft end of the expandable frame and frame struts;

[0022]FIG. 3 diagrammatically illustrates the bent region of the framestrut and the partial wrap of non-perforated material around that bentregion;

[0023]FIG. 4A diagrammatically illustrates the radially closed compactform of the expandable frame extending over the guide wire;

[0024]FIG. 4B diagrammatically illustrates the expandable frame filterin a radially closed compact form, on a guide wire and linked to anactuation tube and proximal lock with a catheter deployed at a proximalend of the filter, frame and actuator system;

[0025]FIG. 4C diagrammatically illustrates frame filter, the actuatorand the flexible end piece at the distal end of the actuator;

[0026]FIG. 5 diagrammatically illustrates a cross-section of theradially closed compact form filter and illustrates the perforatedfilter material furled within the closed compact form of the expandableframe (the material being furled prior to deployment);

[0027]FIGS. 6A and 6B diagrammatically illustrate perspective views ofthe deployed expandable frame with the filter material on the outside ofthe frame struts and the filter material on the inside of the framestruts, respectively;

[0028]FIG. 6C diagrammatically illustrates a perspective view of adeployed expandable frame with perforated filter material without thedelineation of the bent region for the frame members;

[0029]FIG. 6D diagrammatically illustrates the non-perforated materialdisposed around the bent transition region of the frame and thebeginning of the perforated filter area;

[0030]FIGS. 6E, 6F and 6G diagrammatically illustrate a deployedexpandable frame in a fully open state with filter material having ascalloped edge, a partially closed state, and a further closed state(the fully closed state diagrammatically illustrated in FIGS. 4A and 5);

[0031]FIGS. 7 and 8A diagrammatically illustrate a cross-sectional viewof the expandable frame and frame struts without the filter material anda perspective view of the deployed frame struts, respectively;

[0032]FIG. 8B diagrammatically illustrates a plane view of thetransitional bent region of the frame struts;

[0033]FIG. 9 diagrammatically illustrates the expandable frame anddeployed filter material mounted on the guide wire and utilized inconnection with a balloon catheter;

[0034]FIGS. 10, 11 and 12 diagrammatically illustrate various stops andlatch mechanisms operable in connection with the filter device;

[0035]FIG. 13 diagrammatically illustrates a further lock and latchsystem in order to operate the expandable frame;

[0036]FIG. 14 diagrammatically illustrates a threaded lock between theexpandable frame filter and the actuation tube;

[0037]FIGS. 15A and 15B diagrammatically illustrate actuator tubelatches at the proximal end of the guard wire, blood filter frame andactuator tube;

[0038]FIG. 16A diagrammatically illustrates a deployed filter and theposition of the “light touch” latch at the proximal end of the actuatortube (and the introduction of a catheter tube over the filter system andactuator tube);

[0039]FIG. 16B diagrammatically illustrates a detailed view of a guidewire and the light touch, filter deployed latch system;

[0040]FIG. 16C diagrammatically illustrates the proximal end of theactuator tube latch;

[0041]FIG. 17 diagrammatically illustrates the catheter tube beingintroduced over the actuator tube;

[0042]FIGS. 18A, 18B and 18C diagrammatically illustrate the positionalrelationship of the catch or latch ring on the latch tube of theactuator for the fully radially closed position (FIG. 4A), a partiallydeployed position and a radially fully opened position (FIG. 1);

[0043]FIG. 19 diagrammatically illustrates a thread control to manuallydeploy the filter, the thread control established between the threadedcatch on the guide wire and the threads at the proximal end of theactuator cylinder;

[0044]FIG. 20 diagrammatically illustrates a latch cylinder with indiciamarking the radial deployment of the filter at the distal end of thesystem;

[0045]FIGS. 21A and 21B graphically and conceptually illustrate afriction locking mechanism utilized to lock the controllable deploymentsystem in a forward or deployed position;

[0046]FIG. 22 diagrammatically illustrates a side view of the actuatorsleeve and a locking mechanism to lock the controllable deploymentsystem in a forward or deployed position;

[0047]FIG. 23A, 23B diagrammatically illustrate a cross-sectional viewof the locking mechanism illustrated in FIG. 22 from the perspective ofline 23AB′-23AB″;

[0048]FIG. 24 diagrammatically illustrates the actuator sleeve and alocking mechanism to lock the controllable deployment system in arearward or non-deployed position;

[0049]FIG. 25A diagrammatically illustrates the controllable deploymentsystem with a radially closed expandable frame and with a frictionlocking mechanism capable of locking the expandable frame in a radiallydeployed position;

[0050]FIG. 25B diagrammatically illustrates the controllable deploymentsystem with a radially opened expandable frame and with a lockingmechanism capable of locking the expandable frame in a radially closedposition;

[0051]FIGS. 26A, 26B, 26C, 26D and 26E diagrammatically illustrate afriction locking mechanism capable of locking the deployment systemduring radial opening and closing of the expandable frame;

[0052]FIGS. 27A, 27B and 27C diagrammatically illustrate the deploymentsystem with the locking mechanism and corresponding expandable frame inthree different positions;

[0053]FIG. 28 diagrammatically illustrates the placement of theexpandable frame and actuator sleeve over a two-piece segmented guidewire;

[0054]FIG. 29 diagrammatically illustrates the deployment system with adetachably coupled locking mechanism shown with the proximal end of theguide wire and actuation sleeve separated from the distal counterparts;

[0055]FIG. 30 diagrammatically illustrates the deployment system with apartially detachably coupled locking mechanism in a decoupled state;

[0056]FIG. 31 diagrammatically illustrates the deployment system withthe actuator sleeve and expandable frame partially slid over the guidewire;

[0057]FIG. 32 diagrammatically illustrates a cross section view of theactuation sleeve including a deployment marker in a closed position;

[0058]FIG. 33 diagrammatically illustrates a cross section view of theactuation sleeve including a deployment marker in an open position;

[0059]FIG. 34 diagrammatically illustrates the expandable frame anddeployment marker in an expanded position;

[0060]FIG. 35 diagrammatically illustrates a proximal actuator, andparticularly the deployment handle in accordance with the presentinvention;

[0061]FIG. 36 diagrammatically illustrates an exploded view of exemplaryembodiment of the deployment handle of FIG. 35;

[0062]FIG. 37 diagrammatically illustrates a side view of the deploymenthandle of FIG. 36;

[0063]FIG. 38 diagrammatically illustrates the retaining device of thedeployment handle of FIG. 36; and

[0064]FIG. 39 diagrammatically illustrated the alignment indicator andchannel of the deployment handle of FIG. 36.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0065] The present invention relates to a proximal actuator which can betransversely or laterally removably attached to a medical device systemhaving one tube or wire which axially moves with respect to another tubeor wire. As an example, the proximal actuator—deployment system isoperable on a guide wire and an actuator sleeve which opens and closesan expandable frame utilized during catheterization.

[0066]FIG. 1 diagrammatically illustrates a cross-sectional view offilter device 10 generally freely traveling on guide wire 12. In oneembodiment, filter 10 can rotate and move longitudinally over guide wire12 except for longitudinal movement beyond stop 16 towards distal endregion 14 of the wire 12, otherwise the filter's proximal end freelymoves longitudinally over the guide wire. More importantly, the guidewire 12 moves freely through filter device 10. Guide wire 12 has aproximal end shown by arrow 18. Stop 16 is mounted near the distal endof the guide wire.

[0067] Filter device 10 includes an expandable frame 20 formed of aplurality of radiopaque frame struts. The frame struts are coated withradiopaque material 41 such as gold or platinum such that the surgeoncan see the filter on a radiologic monitor. Prior art devices onlyincluded radiopaque fore and aft rings. These radiopaque rings weresometimes difficult to see on radiologic monitors during the surgicaloperation. By coating the frame struts with gold (radiopaque material41), the entire frame is visible on radiologic monitors. Further, theviewing angle for the radiologic sensing device is no longer an issuewhen the frame struts are coated. Frame struts 21, 23, 25 and 27 areidentified in the cross-sectional view of FIG. 1. In a preferredembodiment, each of the frame struts 21, 23, 25 and 27 have a bentregion 22. In a preferred embodiment, bent region 22 is preformed and iscentrally located generally midway between the fore region 24 and theaft region 26 of expandable frame 20 on frame struts 21, 23, 25 and 27.

[0068] In the radially deployed state, expandable frame 20 forms a pairof facing, frustoconical frame structures 6, 28. The mouth offrustoconical frame structure 6 in the illustrated embodiment isupstream of fore end 24. As implied earlier, the term “upstream” refersto a position opposite the direction of blood flow 30 shown by thesingle headed arrow in FIG. 1.

[0069] Filter material 32 (typically PET material having perforations(generally 80 holes, 400 microns each)), is attached to frame struts 21,23, 25 and 27 forming frustoconical frame structure 6. In FIG. 1, filtermaterial 32 is attached to the outside of frame struts 21, 23, 25 and 27(FIG. 1 representing a cross-sectional view of the deployed filterdevice 10). The aft end of filter material 32 (proximally disposed withrespect to fore end 24 of filter device 10), has a non-perforated ordrilled material region about bend transition region 22. This is bettershown in FIG. 3 which is discussed below. The non-perforated regionenhances a sealing against the lumen of the blood vessel.

[0070] One functional feature involves the free movement of guide wire12 within and through filter device 10. This freedom of movement, bothradially and longitudinally along the length of the guide wire isaccomplished by fore and aft collars 11, 34 of the filter 10. In anotherembodiment, the aft end of the frame struts is longitudinally freelydisposed on the guide wire and the fore end of the frame struts is fixedto the guide wire.

[0071]FIG. 2 diagrammatically illustrates aft collar 34 movably disposedon guide wire 12. Similar numerals designate similar items throughoutthe drawings.

[0072]FIG. 3 diagrammatically illustrates frame strut 21 having benttransition region 22. Filter material 32 has a non-perforated materialportion in bent region 22. Non-filtering region 22 generally restrictsblood flow therethrough. This general flow resistant region 22 ofmaterial 32 operates differently compared to blood flow region of filter32. Blood flow is generally shown by arrow 30 in FIG. 1. The materialutilized for filter 32 in the blood flow region 33 (FIG. 3) is drilledor perforated. Other filters are known to persons of ordinary skill inthe art. Generally, blood molecules flow through filter flow region ofmaterial 32 at region 33 but embolic material is captured by the filterthereat. These embolic materials are sometimes created by ballooncatheterization, stenting or other surgical techniques acting on asurgical site upstream of filter device 10. This is illustrated andgenerally described later in connection with FIG. 9.

[0073]FIG. 4A diagrammatically illustrates filter device 10 in aradially compact form prior to deployment of the expandable frame. Guidewire 12 includes a coiled tapered end 13 at distal region 14. In somesituations, the end 13 of guide wire 12 may be curved to enable thephysician to better guide and place the guide wire in the desired vesselof the patient. See the curved blood vessel in FIG. 9. Filter device 10includes a generally cylindrical fore end piece 40 and a tapered foreend segment 42. At aft end segment 26, filter device 10 includes anactuation sleeve or tube 44 which extends in direction 18 to theproximal end of the guide wire (not shown). FIG. 4A also shows a furthersurgical instrument 48 which is utilized by the physician to repair,replace, mount a stent or utilize another biomedical structure or toolat an upstream location with respect filter device 10. Instrument 48 iscommonly called a catheter.

[0074]FIG. 4C diagrammatically illustrates filter device 10 with aflexible end piece 63 formed as part of actuator sleeve 44. Flexible endpiece is a coil strain relief for the catheter assembly. The distal end61 of actuator sleeve 44 tapers down to a coiled end piece section 63.The end piece section 63 is fixed to the proximal or aft collar 26 ofthe frame struts. Therefore, actuator sleeve 44 includes a coiledtapered end 63 at its distal region which permits the entire distal endassembly, filter 10, tip 12 and frame struts 29 et seq., to flex indirections 67 a and 67 b as needed by the surgeon. This high degree offlexibility, typically in excess of 90 degrees from the axial centerlineof the guide wire, is helpful to guide the system through the vascularsystem of the patient. Additionally, the flexible end piece 63 providesa smooth transition to the filter basket. See the curved blood vessel inFIG. 9. FIG. 4C also shows a further surgical instrument 48 which isutilized by the physician to repair, replace, mount a stent or utilizeanother biomedical structure or tool at an upstream location withrespect filter device 10.

[0075] In general, the operation of filter device 10 is as follows. Thephysician deploys the guide wire 12 in the blood vessel of the patientat or near the surgical site of interest. Filter device 10 iscustomarily carried by guide wire 12 through the vascular system. Hencein one embodiment, rotational and longitudinal freedom of movement offilter device 10 (integrated with actuation sleeve 44) with respect toguide wire 12 is important. In another, only the rear end of the frameof struts moves longitudinally with respect to the guide wire. Thefilter device 10 and actuation sleeve 44 runs with guide wire 12 as anintegrated system or unit. See FIG. 4B.

[0076] Either before or after the physician threads or places ballooncatheter or other surgical device 48 over the actuation sleeve 44 andhence over guide wire 12, the physician may radially deploy theexpandable frame 10 in the following manner. The fore end 42 ofexpandable filter device 10 contacts stop 16 on guide wire 12.Otherwise, the for end is fixed to the guide wire. This position isshown diagrammatically in FIG. 1. Before such contact, the physician maytwist (torque) the guide wire through the vascular system. The surgeonsees the filter via radiologic monitoring system and the radiopaque orgold coating on the frame struts greatly assists this viewing process.The guide wire freely moves rotatably and longitudinally through thefilter device 10 (except for movement beyond stop 16).

[0077] At that point in time or shortly thereafter at stop 16 (orotherwise if the filter is fixed to the guide wire end), the physiciancontinues to exert a forward force on filter actuation tube or sleeve 44in the longitudinal or axial direction with respect to guide wire 12(e.g. pulling the guide wire while pushing actuation tube 44) therebycausing compression of filter 10 and sleeve 44 and frame struts 21, 23,25, 27, 28, 29 and 31 and causing the struts to radially expand to theposition shown in FIG. 1. Radial expansion is limited by either theinterior size of the blood vessel or the mechanical limits of thenon-filter material about bent region 22. In the pre-deployed state andin a preferred embodiment, filter material 32 is furled within radialcompact structure.

[0078] The operation of actuation sleeve 44 and actuator piece 115(shown in FIG. 4B) is discussed later in detail in connection with FIGS.15A, 15B, 16A, 17, 16B, 16C, 18A, 18B, 18C. Alternative actuator andlatch systems are shown in FIG. 19.

[0079]FIG. 5 diagrammatically shows filter material 32 furled ordisposed in the interior of the closed radially compact form ofexpandable frame 20. FIG. 5 shows expandable frame 20 with frame struts21, 23, 25, 27, 29 and 31.

[0080] After deployment and formation of frustoconical frame structures6, 28, the physician (a) threads device 48 (e.g. catheter 48) over guidewire 12 and actuation sleeve 44 and (b) activates the balloon catheteror other biomedical device 48 which is upstream, relative to blood flow,of the deployed expandable frame 10. After the surgical procedure withbiomedical device 48, expandable frame 10 is collapsed by the physicianor other medical technician by longitudinally pulling actuation sleeve44 in a proximal direction relative to the guide wire 12. The collapseof expandable frame 10 is achieved by (a) temporary retention of thefore end 40, 42 of expandable frame 10 or (b) closing spring action ofthe frame or (c) both retention and closing spring action. Temporaryretention of the frame is shown diagrammatically with certain lock orlatch structures in FIGS. 10-12 which are discussed later. Uponcollapse, filter 32 captures and entraps embolic material and thisembolic material is withdrawn from the blood vessel of the patient byproximal withdrawal of actuation sleeve 44 and expandable frame filterdevice 10 over guide wire 12.

[0081]FIGS. 6A and 6B diagrammatically illustrate filter material 32 onthe outside of frame struts 21, 23, 25, 27, 29 and 31 and on the insideof those frame struts, respectively.

[0082]FIG. 6C diagrammatically illustrates filter device 10 in aradially deployed state. Filter material 32 has a filtering regionsubstantially covering frustoconical frame structure 6. However, thereis no clear demarcation (other than the absence of holes and passageways) between filter material 32 and peripheral bend region 22 which isa non-filter region.

[0083]FIG. 6D diagrammatically illustrates a plane view showingnon-filter region 22 and the filter region 33 from the perspective of aportion of section line D′-D″ in FIG. 6C.

[0084]FIGS. 6E, 6F and 6G diagrammatically show a scalloped edge in thenon-filter bend region 22-22 a. FIGS. 6F and 6G diagrammaticallyillustrate various collapsed states or positions for frustoconical framestructure 6. The utilization of scallop or concave edge regions spanningadjacent struts (see concave or scallop edge region 120 between theadjacent struts 21, 31), enable the filter material 32 to furl andgather either beneath the frame strut (FIG. 6B) or about the frame strut(FIG. 6A) in order to achieve radial containment upon collapse and priorto withdrawal similar to that illustrated in FIG. 5. FIG. 6Fdiagrammatically illustrates that filter material 32 gathers and furlsupon partial radial collapse of frustoconical frame structure 6 due tothe concave or scallop nature of the material between the complementaryframe struts, that is complementary to adjacent struts 21, 31. FIG. 6Gshows that concave edge 120 promotes gathering of filter material 32between the complementary frame struts associated with struts 21, 31. Asused herein, the term “complementary frame struts” refers to strutsattached to adjacent struts 21, 31 and struts which form thefrustoconical frame structure 6 upon which is disposed filter material32.

[0085]FIGS. 6E, 6F and 6G diagrammatically illustrates that filterdevice 10 can be constructed to collapse and gather the filter material32 as an umbrella.

[0086]FIGS. 7 and 8A diagrammatically illustrate a cross sectional viewand a perspective view of the deployed frame struts 21, 23, 25, 27, 29and 31. FIG. 8A diagrammatically shows an additional frame strut 33.Accordingly, filter device 10 can include a plurality of frame struts ifnecessary. FIG. 8A also diagrammatically shows the bend transitionregion 33 a for frame strut 33. In a preferred embodiment the framestruts are preformed (pre-shaped) and bent at transition region 33 asuch that upon axial or longitudinal compression between stop 16 and theproximal region of guide 12, the frame struts expand at a predeterminedcommon point. Preferably, the common point is centrally located on thestruts. Preferably, the struts also have a “memory” which biases thestruts to a closed position. See FIG. 4A. FIG. 8B shows a furtherenhancement wherein the struts are notched at 35 a, 35 b to facilitate aconsistent and predictable bent region 33 a. Notches or cutouts 35 a, 35b are preferably disposed at the midpoint of complementary frame strutmembers.

[0087]FIG. 9 diagrammatically illustrates the deployed filter device 10disposed in a blood vessel 90 of a patient. Guide wire 12 has beengenerally placed near the site of interest and slightly distally beyondthe site of interest. The site of interest is partial blockage orocclusion 92 in blood vessel 90 of the patient. It is desirable to haveguide wire 12 move, with respect to filter 10, freely both radially andlongitudinally except filter 10 will not move distally beyond stop 16 onguide wire 12. This freedom of movement (two degrees of freedom) permitsthe guide wire to move through the blood vessel 90 and particularlyabout blood vessel bend 91. In operation, the physician deploysexpandable frame 10 downstream of medical device or catheter 48 relativeto blood flow 30. Device 48 is placed and runs over the outside ofactuation tube or sleeve 44 which is operatively associated with aft endregion 26 of filter device 10. By longitudinal compression (a forcedirected distally by the physician via actuation sleeve 44), filterdevice 10 radially expands thereby deploying filter material 32. Filtermaterial 32 has a filter size (perforations or hole diameter 400microns) adequate to capture embolic material which may be dislodged bythe medical procedure at site 92 upstream of filter 10. Biomedicaldevice 48 in FIG. 9 is a general illustration of a balloon catheter.Actuator sleeve 44 and the collapsed filter device 10 easily passeswithin a 0.05 inch lumen of catheter 48.

[0088] FIGS. 10-12 diagrammatically illustrate various stopconfigurations and latches to enable (a) deployment of filter material32 and (b) collapse and retrieval of the filter device 10 from surgicalsite 92. FIG. 10 illustrates stop 16 as a ring attached to guide wire12. The fore end piece 42 of filter device 10 includes a channel 50which is complementary or slightly smaller than guide ring-stop 16. Whenguide ring 16 is placed in channel 50 of fore piece 42, filter device 10is latched onto and temporarily locked to guide wire 12. This latch orlock permits both radial deployment of filter 32 (see FIGS. 1 and 9) andalso permits the closure of the filter by proximally moving actuationsleeve 44 in a direction away from ring stop 16. This movement isrelative to the guide wire.

[0089]FIG. 11 shows a cylindrical stop 16 having a generally cylindricalbody 17 and a protruding ring 19. Fore end piece 42 of filter device 10includes a complementary cavity 50, complementary to the shape of ringlike protrusion 19 and a larger fore end cavity 51 which iscomplementary to the aft end shape of cylindrical fixed stop collar 17.The operation is substantially similar as that discussed above inconnection with FIG. 10.

[0090]FIG. 12 diagrammatically illustrates another configuration of stopand latch 16 which includes a radially inboard aft channel 13. The foreend 42 of filter device 10 includes a protruding end piece 52 that iscomplementary to aft end channel 13 of fixed lock collar stop 16. Again,the physician distally moves filter device 10 until fore end key piece52 locks into channel 13 of collar stop 16. Further distal movement ofactuation sleeve 44 over guide wire 12 (which is static or “not moving”)causes radial deployment of the expandable frame struts of filter device10. To withdraw the filter device 10, the physician proximally pullsactuation sleeve 44 thereby collapsing the frame struts, collapsing thefrustoconical frame structure 6 (FIG. 1), collapsing filter material 32and capturing any embolic material which did not pass through filtermaterial 32. Typically, the collapse is assisted by the closing springaction of the frame struts. The lock and latch system consisting ofchannel 13 and key latch 52 is strong enough to result in the collapseof the frame strut and the filter mesh. Upon further proximal movementof actuation sleeve 44 and after full collapse of the expandable frame10, the locking force of channel 13 and lock latch 52 is overcome by thepulling force of the physician, fore end latch piece 52 exits lockingchannel 13 and the filter device 10 is withdrawn from the blood vessel90.

[0091]FIG. 13 diagrammatically illustrates an aft end locking latchsystem. Aft end region 26 of filter device 10 includes an aftcylindrical end 55 with a ring collar 56. Actuation sleeve 44 includes afore end piece 45 with a locking complementary channel 47 and alongitudinally larger mating channel 49. Mating channel 49 passes overthe aft end of aft member 55 of filter device 10. Locking channel 47 iscomplementary to the shape of collar protrusion 56 thereby enabling theactuation sleeve 44 to latch onto the ring collar 56. In this manner,the actuation sleeve 44 can be attached and detached from the filterdevice 10. If detached, the balloon catheter or other biomedical device48 travels directly over the guide wire rather than over actuationsleeve 44. The forces necessary to latch and unlatch the fore end 40, 42of filter device 10 must be commensurate or balanced with respect to thelocking and latching features on the aft end 55, 56 of filter device 10.

[0092] In addition, FIG. 14 shows that aft end piece 55 of filter 10 canbe threaded and carry a set of threads 60 which are complementary tothread set 62 on actuation sleeve 44. By locking and latching the foreend of filter 10 via one or more of the systems shown in FIGS. 10-12,the actuation sleeve 44 can be threaded onto aft piece 55 of filterdevice 10. Of course, the male and female thread features of the systemshown in FIG. 14 can be reversed such that aft 55 defines female threadsand actuation sleeve 44 carries male threads.

[0093] As discussed earlier in connection with FIG. 4B, filter 10operates based upon longitudinal movement of actuator sleeve or tube 44.Longitudinal movement 112 is noted with respect to filter device 10,actuator 44 with respect to guide wire 12.

[0094] It is important that the physician be notified tactually (viatouch) and visually that filter device 10 is approaching distal end stop16 which is permanently affixed to guide wire 12. In order to providesuch notification, FIG. 4B utilizes three temporary stops or latchpoints 116, 117, 118. However, it should be noted that only a singletemporary stop or latch point 116 may be utilized.

[0095]FIG. 15A diagrammatically illustrates a partial, cross-sectionaldetailed view of actuator piece 115 which is part of actuator sleeve 44.Preferably, actuator piece 115 is cylindrical and is made with a morerigid material as compared with actuator sleeve 44. Most of thematerials utilized in connection with filter device 10 and actuatorsleeve 44 are stainless steel. Filter struts are preferably Ni Ti.Filter material 32 is preferably drilled (with a laser) and filtermaterial 32 and non-filter region 22 is preferably made of PET. Actuatorpiece 115 is preferably a tube of NiTi. Other materials may be utilizedas known to persons of ordinary skill in the art.

[0096] In the illustrated embodiment of FIGS. 4B and 15A, three stops(temporary stops) or latch points 116, 117 and 118 are utilized.Temporary stop 118 provides an initial indication to the physician thatfilter device 10 is soon approaching distal end stop 16. Intermediatetemporary stop 117 is a tactile and a visual notice of the closeapproach of nose piece 42 to stop 16.

[0097]FIG. 15A diagrammatically shows that temporary stop 117 has aslightly larger outside diameter as compared with the inside diameter ofactuator piece 115. As described later, actuator piece 115 has alongitudinal slot 132 therethrough which permits the aft region ofactuator piece 115 to move radially. Accordingly, the physician ispermitted to hold or withdraw actuator piece 115 in the direction shownby arrow 112 a in FIG. 15A thereby causing actuator piece 115 toradially expand and “jump over” temporary stop 117.

[0098]FIG. 15B diagrammatically shows the slight radial overlap betweentemporary stop 116 and actuator piece 115. All latch points 116, 117,118 have a similar radial relationship with respect to the interior orinner diameter of actuator piece 115. Accordingly, every time aft edge134 of actuator piece 115 passes over temporary stop or latch points116, 117, 118, the physician is tactually notified and can visuallyconfirm the position of filter device 10 in relation to distal end stop16. By providing consistent, repeatable and reportable distancerelationships between stops 116, 117, 118 and the radial deploymentand/or longitudinal position of the filter basket and distal end stop16, the physician or the operator can easily control the distance andradial expansion (and contraction) of filter device 10 in relation toend stop 16.

[0099] More importantly, distal end stop 116 is utilized to expandfilter device 10 as shown in FIG. 16A.

[0100]FIG. 16A diagrammatically illustrates a radially expanded filterdevice 10 which is achieved by the physician longitudinally pushingactuator sleeve 44 such that actuator piece 115 is distally located orlongitudinally inboard with respect to temporary stop or latch point116. Even with filter 10 radially deployed as shown in FIG. 16A, thephysician can easily rotate guide wire 12 as shown by double headedarrow 110 and also move the entire guide wire and temporarily latchedand deployed filter 10 in the direction shown by double headed arrow112. FIG. 16A also shows that biomedical device or catheter 48 can befed over temporary stops 116, 117, 118, actuator piece 115, actuatorsleeve 44 and lead to a point near the aft end of deployed filter device10.

[0101]FIG. 17 shows catheter 48 extending over actuator sleeve 44. Guidewire 12 protrudes proximally out of the rear end of catheter biomedicalinstrument 48.

[0102] In order to radially collapse filter device 10, the physicianpulls actuator piece 115 in the direction shown by arrow 112 a in FIG.16A thereby overcoming the temporary latch 116, partially radiallyexpanding actuator piece 115 and longitudinally withdrawing actuatorsleeve 44 with respect to guide wire 12. As discussed earlier, the framestruts form filter device 10 preferably have a memory which biases theframe struts to a closed position. This feature enhances closure of thefilter device 10.

[0103]FIG. 16B diagrammatically illustrates actuator piece 115 disposedat the proximal end of actuator sleeve 44. Actuator piece 115 includes alongitudinal slot 132. The proximal end 134 of actuator piece 115 istemporarily caught on latch point 116. It should be noted that actuatorpiece 115 may have a plurality of slots or may be made of a materialwhich easily radially expands in order to overcome temporary latchpoints 116, 117, 118. Also, rather than having square peripheral edges,the latch point edges may be rounded. Other latch point shapes may beutilized.

[0104]FIG. 16C provides a detailed view of slot 132 and actuator piece115.

[0105]FIGS. 18A, 18B and 18C diagrammatically illustrate the variouspositional aspects of actuator piece 115 in relation to criticaltemporary latch point 116. In FIG. 18A, latch point 116 is at an inboardposition relative to actuator piece 115. Temporary latch point 116 is“critical” to the physician's ability to (a) locate the expandableframe's position relative to a fixed point on the guide wire and/or (b)determine the radial span of the frame. The physician can easily rotateguide wire 12 in the direction shown by double headed arrow 110 and mayalso longitudinally move guide wire 12 in relation to filter device 10as shown by double headed arrow 112. In FIG. 18B, latch point 116 isdisposed beneath slot 132. This position provides several advantages.First, the physician may tactually and visually see temporary latch 116as it travels within slot 132. Preferably, upon visual or tactileconfirmation that sleeve 115 as been placed such that latch 116 isadjacent slot 132, the filter device 10 is radially deployed at variouspositionally related states of radial deployment. In other words, whenactuator piece 115 is positioned such that temporary latch 116 isdisposed at or near the inboard or distal end of slot 132, thefrustoconical frame 6 begins to radially open filter material 32(assuming that the actuator is moving distally with respect to astationary guide wire). At the slot mid-point (FIG. 18B), frustoconicalframe 6 is approximately 50% radially open. When actuator piece 115 iscompletely disposed inboard or at a distal position relative totemporary latch point 116 (FIG. 18C), frustoconical frame structure 6 isfully radially deployed.

[0106]FIG. 20 diagrammatical illustrates actuator piece 115 havingvarious indicia or markings 170, 171, 172, 173 which show and provide avisual indication to the physician that the filter device 10 begins itsopening sequence (indicia 170), is 25% open (indicia 171), is 50% open(indicia 172), is 75% open (point 173) and is fully open when proximalend 134 of actuator piece 115 is located at an inboard or distalposition relative to temporary latch point 116. Indicia 170, 171, 172and 173 are used in connection with temporary latch points on the guidewire as explained above in connection with FIGS. 18A-18C to show radialspan and/or relative longitudinal position of the frame on the guidewire.

[0107] Other types of temporary latches or stops can be provided at theproximal end of actuator sleeve 44. For example, FIG. 19diagrammatically illustrates that critical latch 116 a has a male threaddefined thereon and a proximal region 180 of actuator piece 115 has afemale thread thereon. When the male thread of latch 116 a mates withthe female thread on proximal region 180 of actuator piece 115, filterdevice 10 begins to radially deploy. Upon rotation in a direction, forexample direction 110 a, the physician by rotating actuator piece 115radially expands filter device 10 by further threading threaded membersection 180 of actuator piece 115 over threaded latch 116 a. Threadedtemporary latch 116 a may be used with the slot 132 (FIG. 16B) orindicia 170 et seq. (FIG. 20) to provide visual positional dataregarding the system.

[0108] In some situations, embolic material trapped in the filter maylimit full radial closure of the filter (to a state similar to FIG. 4A).If the embolic material carrying filter is radially large (relative tothe fully closed position FIG. 4A), the physician, subsequent to thewithdrawal of the catheter, (a) places a guide wire extender on theproximal end of the guide wire; (b) longitudinally withdraws theactuator tube and the “full” filter basket while leaving the distal endof the guide wire at the point of interest; (c) withdraws the filterbasket proximally beyond the guide wire extender; (d) unmounts theextender from the guide wire proper; and (e) proceeds with othersurgical techniques (which may include the use of a new filter basketand/or a catheter or stent). This procedure is particularly useful whena stent is placed in the patient's blood vessel.

[0109] Some surgical techniques utilizing the deployment system 70described herein may be made easier and less risky if the expandableframe 20 can be locked in a radially open (deployed) state or in aradially closed state. For example, if a medical practitioner wasperforming a balloon angioplasty, it would helpful to have a filterlocked in a deployed state downstream from the target site of theatherosclerotically obstructed artery in order to capture any embolicmaterials loosened during the procedure. As discussed above inconnection with the filter basket, some circumstances require that theexpandable basket be locked in substantially radially open and radiallyclosed states. FIGS. 21 through 31 illustrate a locking mechanism usedto lock the distally located radially expandable frame 20 (with orwithout the filter) in a closed, radially compact form, and in an open,radially expanded form.

[0110]FIGS. 21A and 21B graphically and conceptually illustrate alocking mechanism 200 preferably located at the proximal end ofdeployment system 70. The friction lock could be deployed at a distalposition if a lock or latch mechanism is necessary thereat. Lockingmechanism 200 includes a first locking member 210 with a radiallyinboard sloped locking surface 220. First locking member 210 ispreferably disposed on the proximal end of the actuator sleeve 44 (seeFIG. 22) or actuator piece 115 (see FIGS. 18A, 18B and 18C). Firstlocking member 210 may be made of a plastic or metallic material, andmay be added to actuator sleeve 44 (see FIG. 22), or may be cast as partof a mold, rolled or formed including actuator sleeve 44 (see FIG. 24).Locking mechanism 200 also includes a second locking member 240 with aradially outboard sloped locking surface 250. Second locking member 240is disposed on the proximal end of guide wire 12 near or adjacentlocking member 210. Likewise, second locking member 240 may be made of aplastic or metallic material, and may be added to guide wire 12 (FIG.21A), or may be cast, rolled or formed as part of the proximal end ofguide wire 12 (FIG. 21B).

[0111] In FIGS. 21A and 21B, radially inboard locking surface 220includes a proximal end 224 being radially further inboard than distalend 226, thus defining a sloping or sloped surface. Radially outboardlocking surface 250 has a proximal end 254 which is radially closer orhas a radial dimension generally similar to guide wire 12 than theradial span or radial dimension of distal end 256 which is larger thanthe span at end 254. In FIG. 21A, radially inboard locking surface 220defines a radially inboard friction face with a substantiallycontinuous, substantially constant slope. In other embodiments, theslope may change over the axial span of the lock (from end 254 to end256). Similarly, radially outboard locking surface 250 defines aradially outboard friction face with a generally continuous,substantially constant slope. In FIG. 21B, radially inboard lockingsurface 220 defines a radially inboard face with a substantiallyconstant slope, and includes numerous cavities or indentations 228.Alternatively, a single protrusion or groove may be utilized to providea single, simple latch on the friction face. Radially outboard lockingsurface 250 defines a radially outboard face with a substantiallyconstant slope, and includes numerous projections or protrusions 258.The cavities may be formed on surface 250 and the protrusions on surface220.

[0112]FIG. 22 diagrammatically illustrates locking mechanism 200 on thefilter or expandable frame deployment system. Locking mechanism 200 inFIG. 22 is substantially similar to locking mechanism 200 in FIG. 21A.FIG. 22 includes actuator sleeve 44 attached to locking members 210.

[0113]FIG. 23A diagrammatically illustrates a cross-sectional view oflocking mechanism 200 in FIG. 22 from the perspective of 23AB′-23AB″. InFIG. 23A, first locking member 210 consists of two parts 210 a, 210 b,each attached, formed or mounted on actuator sleeve 44. Each part has acorresponding radially inboard locking surface 220 a, 220 b. Secondlocking member 240 which is attached, formed or mounted on guide wire 12has a radially outboard locking surface 250. The sloped bar-shapedlocking members 210 a, 210 b and surfaces may be formed on the guidewire 12 and the circumferentially uniform locking members may be formedon the actuator sleeve 44.

[0114]FIG. 23B also diagrammatically illustrates a cross-sectional viewof an alternative embodiment of locking mechanism 200 in FIG. 22 fromthe perspective of 23AB′-23AB″. In FIG. 23B, first locking member 210 ishas a circumferentially uniform surface disposed on actuator sleeve 44with radially inboard locking surface 220. Second locking member 240,which is attached to guide wire 12, has a circumferentially uniformsurface with locking radially outboard surface 250. Other alternativesinclude a uniform first locking member 210 with a multiple, radiallyextending arm second locking member 240, and a multiple radiallyextending arm first locking member 210 with a uniform second lockingmember 240.

[0115]FIG. 24 diagrammatically illustrates another embodiment of lockingmechanism 200 located at the proximal end of filter or frame deploymentsystem 70. In FIG. 24, radially inboard locking surface 220 is shownwith distal end 236 being radially further inboard than proximal end234. Radially outboard locking surface 250 is shown with proximal end264 being radially further outboard than distal end 266. Radiallyinboard locking surface 220 defines a radially inboard friction facewith a generally continuous, substantially constant slope. Similarly,radially outboard locking surface 250 defines a radially outboardfriction face with a generally continuous, substantially constant slope.

[0116]FIG. 25A diagrammatically illustrates filter or frame deploymentsystem 70, including locking mechanism 200, actuator sleeve 44 andexpandable frame 10. Expandable frame 10 is in a radially closed form.Expandable frame 10 includes several frame struts (see FIGS. 1, 6A and8A for example) which are diagrammatically illustrated by struts 21 and25, each attached to aft frame collar 46 and fore frame collar 40. Guidewire 12 operates through locking member 200, and passes through actuatorsleeve 44 and expandable frame 10 and is freely movable both radiallyand longitudinally except that actuator sleeve 44 and expandable frame10 cannot move longitudinally beyond distal stop 16 (located at thedistal end of guide wire 12). In FIG. 25A, expandable frame 10 isdistally located on guide wire 12 such that frame collar 40 is adjacentstop 16. Radially outboard locking member 240 on guide wire 12 defines abullet-shape or missile-shape. Radially outboard locking surface 250defines a smooth, continuous convex shape. Radially inboard lockingmember 210 on actuator sleeve 44 includes radially inboard lockingsurface 220 which defines a corresponding smooth, continuous, concavebowl-like shape.

[0117]FIG. 25B diagrammatically illustrates deployment system 70,including locking mechanism 200, actuator sleeve 44 and expandable frame10. In FIG. 25B, expandable frame 10 is in a partially radially openform. Accordingly, aft frame collar 46 and fore frame collar 40 arelongitudinally closer together, giving expandable frame 10 alongitudinally foreshortened form. In FIG. 25B, expandable frame 10 isdistally located on guide wire 12 such that frame collar 40 is adjacentstop 16. Radially outboard locking member 240 defines a frustoconicalshape. Radially outboard locking surface 250 defines a smooth,continuous conical shape. Radially inboard locking member 210 includesradially inboard locking surface 220 which defines a correspondingsmooth, continuous conical shape. Locking mechanism 200 includes anactuator sleeve 44 with a wider diameter at the proximal end and aradially smaller segment 212 which defines radially inboard lockingmember 210.

[0118]FIGS. 26A, 26B, 26C, 26D and 26E diagrammatically illustratevarious configurations and shapes of locking mechanism 200. In FIG. 26A,locking member 210 includes a radially inboard locking surface with twoseparate radially inboard faces 220 a, 220 b. Second locking member 240includes radially outboard locking surfaces with radially inboard faces250 a, 250 b. First locking member 210 defines two inward-facing bowlsand second locking member 240 defines two facing frustoconical shapeswith a gap between the two. In FIG. 26B, locking members 210 and 240 arereversed such that locking member 210 defines two outward-facing bowlswith a gap between the two, and locking member 240 defines two opposingfrustoconical shapes with a gap between the two. In FIG. 26C, lockingmember 210 defines two facing bowls, and locking member 240 defines twofacing frustoconical shapes. In FIG. 26D, locking member 210 defines twooutward-facing bowls, and locking member 240 defines two tear-dropshapes. In FIG. 26E, locking member 210 defines two outward-facingbowls, and locking member 240 defines two opposing frustoconical shapes.

[0119]FIGS. 27A, 27B and 27C diagrammatically illustrate deploymentsystem 70 with expandable frame 10 in three different states and withlocking mechanism 200 in corresponding states. In FIG. 27A, expandableframe 10 is in a fully open position, and corresponding lockingmechanism 200 shows radially inboard locking surface 220 a substantiallycontiguous to radially outboard locking surface 250 a, thus establishinga friction lock. In FIG. 27B, expandable frame 10 is in a partiallydeployed state. The inboard locking surfaces 220 a, 220 b are not incontact with outboard locking surfaces 250 a, 250 b. In FIG. 27C,expandable frame 10 is in a fully closed state. Radially inboard lockingsurface 220 b is substantially contiguous to radially outboard lockingsurface 250 b, establishing a lock thereat.

[0120]FIG. 28 diagrammatically illustrates actuator sleeve 44 andexpandable frame 10 placed over or run over the proximal end of guidewire 12. Expandable frame 10 is in a radially closed form.

[0121]FIG. 29 diagrammatically illustrates deployment system 70 with adetachably coupled locking mechanism 200 with an extender actuatorsleeve segment. Locking mechanism 200 includes a tactile responsiveinterface 270. Interface 270 may also include visual indicators. SeeFIGS. 18B and 20. FIG. 29 includes a two-part guide wire 12 with acoupling 274, 276. Coupling 274, 276 have a threaded interface. Thecoupling could also be a detent-type coupling. Actuator sleeve 44 isalso a detachably coupled two-part actuator. Actuator sleeve 44 has athreaded interface coupling 278, 280 or a detent-lock. In FIG. 29, theproximal end of guide wire 12 and actuation sleeve 44 are separated fromthe distal counterparts. Expandable frame 10 in a radially closed state.

[0122]FIG. 30 diagrammatically illustrates deployment system 70 with apartially detachably coupled locking mechanism 200 in a decoupled state.Expandable frame 10 is locked in a slightly radially deployed state bythe locking of guide wire 12 and actuation sleeve 44 at the distal endof locking mechanism 200. Locking members 210 and 240 are substantiallycontiguous thereby creating the friction lock between guide wire 12 andactuation sleeve 44 when frame 10 is fully open (not shown).

[0123]FIG. 31 diagrammatically illustrates the distal end of deploymentsystem 70 with the actuator sleeve 44 and expandable frame 10 partiallyslid over the guide wire 12. Expandable frame 10 is in radially closedform with frame end 40 not in contact with distal stop 16. Radiallyinboard locking member 240 is not in contact with radially outboardlocking member 210.

[0124] The operation of the friction locking mechanism follows. Lockingmechanism 200 locks expandable frame 10 in a radially open (deployed)state or in a radially closed state. Locking mechanism 200 may includeone friction locking interface as shown in FIGS. 21A, 21B, 22, 24, 25Aand 25B, or may include dual or forward and aft friction lockinginterfaces as shown in FIGS. 26A through 26E, 27A through 27C, 29, 30and 31, thus giving the locking mechanism capability of locking theexpandable frame in both a radially open form and in a closed form.

[0125]FIG. 22 illustrates a locking mechanism used to lock expandableframe 10 in a radially deployed state. Although guide wire 12 andactuation sleeve 44 can be moved longitudinally with respect to eachother, it will be assumed for purposes of describing the operation ofthe locking mechanism that guide wire 12 is stationary. In FIG. 22, theuser pushes actuation sleeve 44 in a distal direction as indicated byarrow D. This longitudinally distal movement of actuation sleeve 44relative to guide wire 12 causes the expandable frame to move distallyover the guide wire until distal or fore frame collar 40 abuts distalstop 16 (see FIG. 25B). Distal stop 16 limits further distal movement ofdistal frame collar 40 along guide wire 12. As the actuation sleeve 44is pushed further, proximal or aft frame collar 46 continues to movedistally causing the frame struts 21 and 25 to radially deploy (see FIG.25B). Thus, as expandable frame 10 opens, it attains an open, radiallyexpanded, longitudinally foreshortened form.

[0126] Locking mechanism 200 also engages during the aforementionedlongitudinally distal movement of actuation sleeve 44 relative to guidewire 12. As actuation sleeve 44 is moved distally, radially inboardlocking surface 220 comes in contact with radially outboard lockingsurface 250. As the two locking surfaces become substantiallycontiguous, the surfaces establish a friction locking interface suchthat actuation sleeve 44 is immobile with respect to the guide wire 12.The slope of the radially inboard friction face defined by lockingsurface 220 and the slope of the radially outboard friction face definedby locking surface 250 determine the duration or displacement of thefriction locking interface established between the two locking surfaces.The more gradual the slope the longer the friction locking interfaceand, thus, the greater the longitudinal displacement of actuation sleeve44. Upon radially opening expandable frame 10 to a predetermineddiameter, the actuation sleeve 44 and the guide wire 12 are lockedtogether by the friction locking interface of locking mechanism 200. Inorder to unlock the locking mechanism, the user pulls on actuationsleeve 44 in a direction opposite arrow D such that the lock establishedby the friction locking interface no longer holds the actuation sleeve44 immobile relative to the guide wire 12.

[0127]FIG. 24 illustrates a locking mechanism used to lock expandableframe 10 in a radially closed state. It will be assumed for purposes ofthe foregoing that expandable frame has been deployed and the distal orfore end 40 of expandable frame 10 is temporarily retained as describedin connection with FIGS. 10 through 12, above. In FIG. 24, the userpulls actuation sleeve 44 in a proximal direction as indicated by arrowP. This longitudinally proximal movement of actuation sleeve 44 relativeto guide wire 12 causes the proximal frame end to move proximally overthe guide wire 12 such that the frame struts move radially inboardtoward the guide wire (see FIG. 25A). The proximal movement of actuationsleeve 44 causes the frame struts to bend toward their approximateoriginal shape until the longitudinal tension overcomes the temporaryretaining force of the temporary latch at distal stop 16. Thus, asexpandable frame 10 closes, it attains a closed, radially compact,elongated form.

[0128] Locking mechanism 200 also engages during the aforementionedlongitudinally proximal movement of actuation sleeve 44 relative toguide wire 12. In FIG. 24, as actuation sleeve 44 is moved proximally,radially inboard locking surface 220 comes in contact with radiallyoutboard locking surface 250. As the two locking surfaces becomesubstantially contiguous, the surfaces establish a friction lockinginterface such that actuation sleeve 44 is immobile with respect to theguide wire 12. Similarly, the slope of the radially inboard frictionface defined by locking surface 220 and the slope of the radiallyoutboard friction face defined by locking surface 250 determine theduration or displacement of the friction locking interface establishedbetween the two locking surfaces. The more gradual the slope the longerthe friction locking interface and, thus, the greater the longitudinaldisplacement of actuation sleeve 44. Upon radially closing expandableframe 10 to a predetermined diameter, the actuation sleeve 44 and theguide wire 12 are locked together by the friction locking interface oflocking mechanism 200. In order to unlock the locking mechanism, theuser pushes on actuation sleeve 44 in a direction opposite arrow P suchthat the lock established by the friction locking interface no longerholds the actuation sleeve 44 immobile relative to the guide wire 12.

[0129]FIG. 21B diagrammatically illustrates an alternative lockinginterface to lock expandable frame 10 in a radially deployed state. InFIG. 21B, radially inboard friction face 220 defines cavities 228 whichinteract with protrusions 258 on radially outboard friction face 250during radial deployment of expandable frame 10. As the two frictionfaces come in contact with each other one or more of protrusions 258align with one or more corresponding cavities 228, thus creating alocking interface with steps in addition to the friction lockinginterface (alternatively, radially inboard face 220 can define theprotrusions and radially outboard face 250 can define the cavities).Additionally, a combination in which both faces define protrusions canalso be utilized. Finally, the aforementioned locking faces may also beutilized to lock expandable frame 10 in a radially closed state.

[0130] The locking mechanism 200 discussed above in connection withFIGS. 22 and 24 can be combined to form a locking mechanism that iscapable of locking the expandable frame in both a radially expanded formand a radially closed form. FIGS. 27A, 27B and 27C illustrate a lockingmechanism 200 capable of locking expandable frame 10 during radiallydeployment and radial closure. In FIG. 27A, actuation sleeve 44 has beenlongitudinally moved in a distal direction such that expandable frame 10is in a radially deployed state and radially inboard locking surface 220a and radially outboard locking surface 250 a are substantiallycontiguous creating a friction locking interface such that actuationsleeve 44 is immobile or locked in position relative to guide wire 12.In FIG. 27A, locking mechanism 200 is disengaged. Radially inboardlocking surfaces 220 a, 220 b are not in contact with correspondingradially outboard locking surfaces 250 a, 250B. Expandable frame 10 isin transition between deployment and closure. In FIG. 27C, actuationsleeve 44 has been longitudinally moved in a proximal direction suchthat expandable frame 10 is in a radially closed form and radiallyinboard locking surface 220 b and radially outboard locking surface 250b are substantially contiguous creating a friction locking interfacesuch that actuation sleeve 44 is immobile or locked in position relativeto guide wire 12.

[0131] As previously discussed in connection with the filter device,there are circumstances in which a physician may need to lock theexpandable frame (with or without the filter) in order to perform othersurgical or medical techniques. During such techniques, it may beconvenient or necessary to remove the locking mechanism 200 from theproximal end of deployment system 70 in order to position otherinstruments or catheters over guide wire 12 and actuation sleeve 44.FIGS. 28, 29, 30 and 31 diagrammatically illustrate a deployment system70 with a detachable locking mechanism 200. In FIG. 29, when lockingmechanism 200 is detached, actuation sleeve 44 and expandable frame 10are free to move longitudinally and radially with respect to guide wire12 (except beyond distal stop 16).

[0132] In FIGS. 29 and 31, actuation sleeve 44 and guide wire 12 includecoupling interfaces which permit the physician to lock the expandableframe 10 in a radially open or deployed state prior to and after removalof the proximal end of locking mechanism 200. FIG. 31 illustrates thedistal end of locking mechanism 200 and deployment system 70 prior todeployment of expandable frame 10. In FIG. 30, actuation sleeve 44 hasbeen longitudinally moved in a distal direction relative to guide wire12 such that expandable frame 10 is radially deployed and radiallyinboard locking member 240 has engaged radially outboard locking member210 establishing a friction locking interface.

[0133] As discussed earlier in connection with the filter device, it isimportant that the physician performing surgical techniques utilizingthe locking mechanism be visually and tactually notified when expandableframe 10 is approaching distal stop 16 and when the expandable frame isin a radially open or closed state. In order to provide suchnotification, locking mechanism 200 in FIGS. 29 and 30 utilizes severalvisual, tactile indicators 270. The indicators may also be utilized astemporary stops or latch points 116, 117, 118, 119. Again, only a singletemporary stop or latch point 116 may be utilized.

[0134] The frame deployment system 70 may be utilized in a number ofmedical procedures such as deployment of a blood filter (see FIG. 1, forexample) or deployment of a frame (see FIG. 8A, for example). The framewith a filter may be utilized in vascular, urologic and othercatheterization procedures. Hence the friction lock can be used in acontrollable deployment system.

[0135] The present invention relates to a proximal actuator for amedical device wherein the medical device, at its proximal end, has onetube or wire which axially moves with respect to another tube or wire.The previous illustrations primarily focus on medical devices operableat the distal end of the control system. The proximal actuator of thepresent invention, when transversely or laterally (not longitudinally)removably mounted on the distal end of the control system, permits theoperator to move one wire or tube with respect to the other wire or tubethereby affecting the operation of the medical device at the distal endof the control system. In one embodiment, the actuator is attached todeployment system for an expandable frame and an associated filtersystem which mounts onto the expandable frame which is used duringcatheterization of a patient. However, the proximal actuator could beused with many types of medical devices distally located on the wirewithin a tube system. The claims appended hereto are meant to cover anymedical device that is controlled by a wire in a tube or a tube within atube, wherein one moves axially with respect to the other.

[0136] Referring to FIGS. 32 and 33, the actuation sleeve 44 (firstmovable member) of the filter device 10 includes a deployment marker 300to indicate radial deployment of the expandable frame 20. The deploymentmarker 300 radially bisects the actuation sleeve 44 into a first section302 and a second section 304, wherein the first section 302 is affixedto the guide wire 12 (second movable member). It should be noted thatalthough first and second movable members are sometimes referred toherein, the salient point is that one member moves longitudinally oraxially with respect to the other member. Both movable members need notmove, but some longitudinal movement of one versus the other isnecessary. Deployment of the expandable frame 20 is indicated by theformation of a gap 306 in the deployment marker 300 between the firstsection 302 and second section 304 of the actuation sleeve 44.

[0137] Referring to FIG. 34, a physician or operator radially deploysthe expandable frame 20 by holding the first section 302 of theactuation sleeve 44 (first movable member) in a fixed position orpulling the first section 302, while exerting a forward force on thesecond section 304 in the longitudinal or axial direction with respectto guide wire 12 (second movable member)(e.g. pushing the second section304) forming a gap 306 in the deployment marker 300. The resultingmovement of the second section 304 of the actuation sleeve 44 causescompression of filter 10, the second section 304 of the actuation sleeve44, and frame struts 21, 23, 25, 27, 28, 29 and 31 causing the struts toradially expand. After the surgical procedure, the expandable frame 20is collapsed by the physician holding the first section 302 of theactuation sleeve 44 in a fixed position or pushing the first section302, while exerting a rearward force on the second section 304 in thelongitudinal or axial direction with respect to guide wire 12 (e.g.pulling the second section 304), closing the gap 306 in the deploymentmarker 300. It should be noted that rather than open and close a frameor filter, any medical device located at a distal position relative tothe proximal, operators position can be manipulated by the proximalactuator discussed herein.

[0138] Referring to FIG. 35, the present invention includes a proximalactuator with deployment handle 308 for radially deploying theexpandable frame 20. The deployment handle actuator 308 includes a firstretaining device 310 and a second retaining device 312 for retaining theactuation sleeve 44. The first retaining device 310 and second retainingdevice 312 are operably connected such that the longitudinal distancebetween the first retaining device 310 and the second retaining device312 is adjustable.

[0139] A physician radially deploys the expandable frame 20 bypositioning the first section 302 of the actuation sleeve 44 (firstmovable member) within the first retaining device 310 and the secondsection 304 of the actuation sleeve 44 within the second retainingdevice 312, wherein the deployment marker 300 is disposed between thefirst retaining device 310 and second retaining device 312. Effectively,the second movable member is either the guide wire or the second section304 of the actuator sleeve which is fixed to the guide wire. Thelongitudinally distance between the first retaining device 310 and thesecond retaining device 312 is increased (the retainers movelongitudinally apart) forming a gap 306 (FIG. 33) in the deploymentmarker 300, thereby causing compression of filter 10, the second section304 of the actuation sleeve 44 and frame struts 21, 23, 25, 27, 28, 29and 31 causing the struts to radially expand. After the surgicalprocedure, the expandable frame 20 (or other medical device) iscollapsed by the physician decreasing the longitudinally the distancebetween the first retaining device 310 and the second retaining device312, closing the gap 306 in the deployment marker 300.

[0140] Referring to FIG. 36, the deployment handle actuator 308 includesa grip portion 314 for supporting the first retaining device 310 and thesecond retaining device 312. The grip portion 314 includes a sleeve 316defining an aperture 318, wherein the first retaining device 310 isaffixed to the sleeve 316. The second retaining device 312 is affixed toa sliding member 320, wherein the sliding member 320 is slidinglypositionable through the aperture 318. The sliding member 320 includes afirst end 322 and a second end 324, wherein the first end 322 ispositionable through the aperture 318 of the sleeve 316 and the secondretaining device 312 is affixed to the second end 324. The slidingmember 320 slides through the aperture 318 such that the longitudinaldistance between the first retaining device 310 and the second retainingdevice 312 can be increased or decreased.

[0141] The sliding member 320 is retained within the aperture 318 by acontrol actuator 328 operably engaging the first end 322 of the slidingmember 320. For example, the sliding end 322 of the sliding member 320includes a threaded portion 330, wherein the control actuator 328threadably engages the threaded portion 330. In addition, the controlactuator 328 is utilized to increase or decrease the longitudinaldistance between the first retaining device 310 and the second retainingdevice 312. For example, the longitudinal distance between the firstretaining device 310 and the second retaining device 312 is increased byrotating the control actuator 328 in a clock wise direction, decreasingthe number of threads engaged by the control actuator 328. Thelongitudinal distance between the first retaining device 310 and thesecond retaining device 312 is decreased by rotating the controlactuator 328 control actuator 328. Alternatively, slide member 320 canbe axially moved without a rotatable control actuator if the controlactuator is a push-pull system. Tactile markers or ribs may indicate theaxial movement of the slide actuator 328 and slide member 320. Anotheralternative embodiment utilizes a squeeze grip which grips one of theguide wire or the actuator sleeve while the other of the guide wire oractuator sleeve is held stationary. Upon compression of the squeeze gripby the operator, the gripper locks onto the moveable element (guide wireor sleeve). Upon release of the squeeze grip, the lock is released. See,for example, U.S. Pat. No. 5,483,952 to Aranyi.

[0142] Referring to FIGS. 37 and 38, the first retaining device 310 andthe second retaining device 312 are spring loaded retention clips,wherein the first retaining device 312 is a handle clip mounted on grip314 and the second retaining device 312 is a slide clip mounted on slidemember 320. The handle clip 310 includes a thumb plate 332 for openingand closing the handle clip 310, wherein when the thumb plate 332 isdepressed the handle clip 310 is opened and when the thumb plate 332 isreleased the handle clip 310 is closed by spring action. Additionally,the thumb plate 332 is of sufficient length (with respect to the guidewire) to engage the slide clip 312 throughout the range of motion of thesliding member 320, such that when the thumb plate 332 is depressed, theslide clip 312 is opened and when the thumb plate 332 is released theslide clip 312 is closed. The handle clip 310 and slide clip 312 eachinclude an alignment indicator 334 for positioning the actuation sleeve44. The alignment indication 334 includes a channel 336, longitudinallytraversing the clips 310, 312, configured for receiving the actuatorsleeve 44. (See also FIG. 39).

[0143] In an exemplary method of use, the deployment handle actuator 308is verified to be in the closed position, wherein the slide clip 312 islocated at a position closest to the handle clip 310 and the thumb plate332 completely overlaps the slide clip 312. The thumb plate 332 isdepressed, concurrently opening the handle clip 310 and the slip clip312. The actuation sleeve 44 is secured within the handle clip 310 andthe slide clip 312, wherein the actuation sleeve 44 is positioned withinthe channels 336 of the alignment indicators 334 to align the actuationsleeve 44. The deployment marker 300 is located between the handle clip310 and the slide clip 312, with the first section 302 of the actuationsleeve 44 positioned within the handle clip 310 and the second section304 of the actuation sleeve 44 position in the slide clip 312. Graphicelements 310 indicate second sleeve section 304 is attached mounted oraffixed to guide wire 12. Alternatively, sleeve section 304 may beeliminated and the guide wire 12 clipped into slide clip 312.

[0144] To radially deploy the expandable frame 20, the control actuator326 is rotated in a clockwise direction until the slide clip 312 islocated at a position furthest from the handle clip 310. Verification ofa gap 306 within the deployment marker 300, between the first section302 and the second section 304 of the actuation sleeve 44 (or the guidewire 12) indicates filter deployment.

[0145] The actuation sleeve 44 is removed from the deployment handle 308by compressing the thumb plate 332 to open the handle clip 310 and theslide clip 312. The surgical procedure is performed.

[0146] To close the expandable frame 20, verify that the deploymenthandle 308 is in the open position, wherein the slide clip 312 islocated at a position furthest from the handle clip 310; and depress thethumb plate 332, opening the handle clip 310 and the slide clip 312. Theactuation sleeve 44 is secured within in the handle clip 310 and theslide clip 312, wherein the actuation sleeve 44 is positioned within thechannels 336 of the alignment indicators 334 to align the actuationsleeve 44. The deployment marker 300 and gap 306 are located between thehandle clip 310 and the slide clip 312, with the first section 302 ofthe actuation sleeve 44 positioned within the handle clip 310 and thesecond section 304 of the actuation sleeve 44 positioned in the slideclip 312.

[0147] Position the actuation sleeve 44 within the handle clip 310 andthe slide clip 312 with the deployment marker 300, and gap 306, locatedbetween the handle clip 310 and the slid clip 312. The first section 302of the actuation sleeve 44 is positioned within the handle clip 310 andthe second section 304 of the actuation sleeve 44 is positioned withinthe slide clip 312. Release the thumb plate 332 to secure the actuationsleeve 44 within the handle clip 310 and the slide clip 312.

[0148] The expandable frame 200 is closed by rotating the controlactuator 332 in a counter-clockwise direction (or other suitabledirection) until the slide clip 312 is located at a position closest tothe handle clip 310. Verify that no gap 306 exists in the deploymentmarker 300 between the first section 302 and the second section 304 ofthe actuation sleeve 44. Depress the thumb plate 44 to open the handleclip 310 and the slide clip 312, and remove the actuation sleeve 44 fromthe deployment handle 308.

[0149] An important feature of the present invention is that theproximal actuator need not be axially threaded onto or off of the guidewire-actuator sleeve system. The proximal actuator is removably mountedto the tube in a tube or wire over a wire system by transversely orlaterally attaching the proximal actuator at a desired location on theguide wire-actuator sleeve. Thereafter, axial movement of the first andsecond movable members (that is, the wire within the tube) is achievedby moving the first and second retainer of the proximal actuator awayfrom each other. A variety of medical devices can be moved at the distalend of the wire in a tube system such as frames (discusses extensivelyabove), balloons, cutting tools, stents, etc.

[0150] It will be appreciated by persons skilled in the art that thepresent invention is not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings without departing from the scope andspirit of the invention, which is limited only by the following claims.

What is claimed is:
 1. A proximal actuator removably attachable to anelongated actuation sleeve having a proximal end and a distal end, theproximal end is divided into a first section and a second section andthe distal end carries a medical device thereat, the proximal actuatorcomprises: a first retaining device laterally removably attachable tothe first section; and a second retaining device laterally removablyattachable to the second section, wherein the second retaining device ismoveable relative to the first retaining device such that the medicaldevice is activated.
 2. The proximal actuator according to claim 1,further comprising a grip portion having a sleeve defining an aperture,wherein the first retaining device is affixed to the sleeve.
 3. Theproximal actuator according to claim 2, further comprising a slidingmember including a first end and a second end, wherein the first end ofthe sliding member is positionable through the aperture of the sleeve.4. The proximal actuator according to claim 3, wherein the secondretaining device is affixed to the second end of the sliding member. 5.The proximal actuator according to claim 4, wherein the first end of thesliding member is threaded.
 6. The proximal actuator according to claim5, further comprising a control actuator moveably engaging the threadedfirst end of the sliding member within the aperture, such that thecontrol actuator moves the second retaining member from a first positionto a second position relative to the first retaining member.
 7. Theproximal actuator according to claim 1, wherein the first retainingdevice is in a fixed position.
 8. The proximal actuator according toclaim 7, wherein the second retaining device is longitudinally movablefrom a first position to a second position relative to the firstretaining member.
 9. The proximal actuator according to claim 1 whereinsaid medical device has at least two a first and a second positionalstate, said first and second sections moving said medical device to oneof said first and said second positional states based upon the movementtherebetween.
 10. The proximal actuator according to claim 1 whereinsaid actuator is mounted over a guide wire.
 11. The proximal actuatoraccording to claim 1, wherein the first retaining device is a firstspring loaded clip.
 12. The proximal actuator according to claim 11,wherein the first spring loaded clip comprises a first alignmentindicator.
 13. The proximal actuator according to claim 11, wherein thesecond retaining device is a second spring loaded clip.
 14. The proximalactuator according to claim 13, wherein the second spring loaded clipcomprises a second alignment indicator.
 15. The proximal actuatoraccording to claim 1 wherein a wire extends through said actuatorsleeve, said wire having a proximal and a distal end, said proximal endof said wire being attached to said second section of said actuatorsleeve.
 16. A proximal actuator removably attachable to a firstelongated movable member and a second elongated movable member, saidfirst and second movable members adapted to move longitudinally withrespect to each other, said first and second movable members havingproximal and distal portions, a medical device mounted on said distalportions of both said first and second movable members, the proximalactuator comprising: a first retaining device laterally removablyattachable to the first movable member; and a second retaining devicelaterally removably attachable to the second movable member, wherein thesecond retaining device is moveable relative to the first retainingdevice such that as the first movable member slides over the secondmovable member to activate said medical device.
 17. A proximal actuatoraccording to claim 16 wherein said first movable member is an actuationsleeve and said second movable member is a wire.
 18. A deployment handleremovably attachable to an expandable device employed duringcatheterization, the expandable device including an actuation sleevehaving a proximal end and a distal end, the proximal end is divided intoa first section and a second section and the distal end has a expandableframe for capturing embolic material, the deployment handle comprises: afirst retaining device removably attachable to the first section; and asecond retaining device removably attachable to the second section,wherein the second retaining device is moveable relative to the firstretaining device such that the expandable frame is opened and closed.19. The deployment handle according to claim 18, further comprising agrip portion having a sleeve defining an aperture, wherein the firstretaining device is affixed to the sleeve.
 20. The deployment handleaccording to claim 19, further comprising a sliding member including afirst end and a second end, wherein the first end of the sliding memberis positionable through the aperture of the sleeve.
 21. The deploymenthandle according to claim 20, wherein the second retaining device isaffixed to the second end of the sliding member.
 22. The deploymenthandle according to claim 21, wherein the first end of the slidingmember is threaded.
 23. The deployment handle according to claim 22,further comprising a control actuator moveably engaging the threadedfirst end of the sliding member within the aperture, such that thecontrol actuator moves the second retaining member from a first positionto a second position relative to the first retaining member.
 24. Thedeployment handle according to claim 18, wherein the first retainingdevice is in a fixed position.
 25. The deployment handle according toclaim 24, wherein the second retaining device is movable from a firstposition to a second position relative to the first retaining member.26. The deployment handle according to claim 25, wherein when the secondretaining device is in the first position, the expandable frame is in aclosed configuration.
 27. The deployment handle according to claim 25,wherein when the second retaining device is in the second position, theexpandable frame is in an open configuration.
 28. The deployment handleaccording to claim 18, wherein the first retaining device is a firstspring loaded clip.
 29. The deployment handle according to claim 28,wherein the first spring loaded clip comprises a first alignmentindicator.
 30. The deployment handle according to claim 28, wherein thesecond retaining device is a second spring loaded clip.
 31. Thedeployment handle according to claim 30, wherein the second springloaded clip comprises a second alignment indicator.
 32. A deploymenthandle removably attachable to an expandable device employed duringcatheterization, the expandable device including an actuation sleevehaving a proximal end and a distal end, the proximal end is divided intoa first section and a second section and the distal end includes anexpandable frame for capturing embolic material, the deployment handlecomprising: a grip portion including a sleeve defining an aperture; afirst retaining device affixed to the sleeve and removeably attachableto the first section of the proximal end of the actuation sleeve; asliding member including a first end and a second end, the first end ofthe sliding member is positionable through the aperture of the sleeve; asecond retaining device affixed to the second end of the sliding memberand removeably attachable to the second section of the proximal end ofthe actuation sleeve; and a control actuator moveably engaging the firstend of the sliding member within the aperture, such that the controlactuator moves the second retaining member from a first position to asecond position relative to the first retaining device such that theexpandable frame is opened and closed.
 33. The deployment handleaccording to claim 32, wherein when the second retaining device is inthe first position, the expandable frame is in a closed configuration.34. The deployment handle according to claim 32, wherein when the secondretaining device is in the second position, the expandable frame is inan open configuration.
 35. The deployment handle according to claim 32,wherein the first retaining device is a first spring loaded clip. 36.The deployment handle according to claim 35, wherein the first springloaded clip comprises a first alignment indicator. 37 The deploymenthandle according to claim 32, wherein the second retaining device is asecond spring loaded clip.
 38. The deployment handle according to claim37, wherein the second spring loaded clip comprises a second alignmentindicator.
 39. A deployment handle removably attachable to an expandabledevice, the expandable device including a wire member and an actuationsleeve slidably disposed about the wire member, the actuation sleevehaving an expandable frame for capturing embolic material, thedeployment handle comprising: a first retaining device removablyattachable to the actuation sleeve; and a second retaining deviceremovably attachable to the wire member, wherein the second retainingdevice is moveable relative to the first retaining device such that asthe actuation sleeve slides over the wire member the expandable frame isopened and closed.
 40. The deployment handle according to claim 39,further comprising a grip portion having a sleeve defining an aperture,wherein the first retaining device is affixed to the sleeve.
 41. Thedeployment handle according to claim 40, further comprising a slidingmember including a first end and a second end, wherein the first end ofthe sliding member is positionable through the aperture of the sleeve.42. The deployment handle according to claim 41, wherein the secondretaining device is affixed to the second end of the sliding member. 43.The deployment handle according to claim 42, wherein the first end ofthe sliding member is threaded.
 44. The deployment handle according toclaim 43, further comprising a control actuator moveably engaging thethreaded first end of the sliding member within the aperture, such thatthe control actuator moves the second retaining member from a firstposition to a second position relative to the first retaining member.45. The deployment handle according to claim 39, wherein the firstretaining device is in a fixed position.
 46. The deployment handleaccording to claim 39, wherein the second retaining device is movablefrom a first position to a second position relative to the firstretaining member.
 47. The deployment handle according to claim 46,wherein when the second retaining device is in the first position theexpandable frame is in a closed configuration.
 48. The deployment handleaccording to claim 46, wherein when the second retaining device is inthe second position the expandable frame is in an open configuration.49. The deployment handle according to claim 39, wherein the firstretaining device is a first spring loaded clip.
 50. The deploymenthandle according to claim 49, wherein the first spring loaded clipcomprises a first alignment indicator.
 51. The deployment handleaccording to claim 49, wherein the second retaining device is a secondspring loaded clip.
 52. The deployment handle according to claim 51,wherein the second spring loaded clip comprises a second alignmentindicator.